Therapeutic Cuddling in Critically Ill Kids (THE ChICKS) Pilot Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Feasibility of randomization
研究概览
简要总结
2.1 CONTEXT Pain and agitation are common comorbidities of pediatric critical illness due to both underlying disease processes and ICU related therapies. These are associated with both short and long term negative sequelae including increased mortality, length of stay, rates of ICU delirium, worse sleep, increased anxiety, depression, and chronic pain. The current standard of care to manage PICU associated pain and agitation is the use of analgosedation (e.g. opioids and benzodiazepines) these too are associated with increased time on the ventilator, length of stay, ICU delirium, and long term mental health and negative neuro-cognitive outcomes. Despite recommendations for increased use of non-pharmacologic therapies in the prevention and management of PICU associated pain, agitation, delirium, and analgosedation exposure, there are currently know therapies with clear evidence of efficacy.
Therapeutic cuddling (e.g. kangaroo care, clothed cuddling, comfort holding, etc.) has been shown to decrease pain and anxiety in critically ill neonates, and healthy children and adults. Positive affective touch and hugging has known physiologic benefits and has been associated with decreased pain, improved immunity, and decreased mortality. Despite the potential for this intervention to aid in the prevention and management of PICU associated pain, agitation, delirium and analgosedation exposure, little data exists on efficacy of therapeutic cuddling in critically ill children.
2.2 OBJECTIVES 2.2.1 Primary Determine the feasibility of screening, consent, randomization, and retention of participants in a pragmatic RCT of therapeutic cuddling versus standard of care in the Alberta Children's Hospital Pediatric Intensive Care Unit.
2.2.2 Secondary
- Determine treatment fidelity of participants randomized to the intervention arm.
- Determine the prevalence of the therapeutic cuddling intervention in those randomized to the standard of care arm.
- Determine the feasibility of measurement of key outcomes and co-variates (i.e., pain, agitation, sedation, delirium, analgosedation exposure, parental presence).
- Describe the experience of patients, caregivers, and healthcare professionals in delivering/receiving the therapeutic cuddling intervention.
2.3 STUDY DESIGN Pilot feasibility randomized controlled trial of a structured co-designed therapeutic cuddling intervention as compared to the standard of care in a single tertiary care PICU.
2.4 DURATION 6 months to 1 year 2.5 LOCATION, DEPARTMENTS, AND FACILITY WHERE RESEARCH WILL BE UNDERTAKEN The pediatric intensive care unit at the Alberta Children's Hospital 2.6 SAMPLE SIZE A total sample size of 112 participants (56 per arm)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- expected duration of admission of > 48 hours.
排除标准
- •Previously enrolled
研究组 & 干预措施
Therapeutic cuddling
Structured therapeutic cuddling intervention prescribed twice daily
干预措施: Therapeutic cuddling (Other)
Standard of Care
No structured therapeutic cuddling prescription, but therapeutic cuddling not prevented.
干预措施: Standard of care (Other)
结局指标
主要结局
Feasibility of randomization
时间窗: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first
Proportion of those consented who are successfully randomized.
Feasibility of consent
时间窗: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first
Proportion of patients who are approached who provide consent.
Ability to retain participants
时间窗: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first
Proportion of randomized participants who complete study procedures
次要结局
- Prevalence of the therapeutic cuddling intervention in those randomized to the standard of care arm(From enrollment up to 14 study days or PICU discharge, whichever occurs first.)
- Feasibility of measurement of key outcomes and co-variates (i.e., pain, agitation, sedation, delirium, analgosedation exposure, parental presence)(From enrollment up to 14 study days or PICU discharge whichever occurs first)
- Describe the experience of patients in receiving the therapeutic cuddling intervention(Until the end of the study period, expected to complete within 18 months.)
- Describe the experiences of parents with therapeutic cuddling(Until the end of the study period, expected to completed within 18 months.)
- Experience of HCP with delivering Therapeutic Cuddling(Until study completion, an average of 18 months)